BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APPLIED MEDICAL

    MDR report key: 3252436 · Received July 23, 2013

    Report

    Report Number
    MW5031085
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 30, 2013
    Report Date
    July 23, 2013
    Manufacturer
    APPLIED MEDICAL
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    APPLIED MEDICAL RETRIEVAL BAG FAILED TO DEPLOY PROPERLY AND FELL BACK INTO PT ABDOMEN DURING A LAPAROSCOPIC PROCEDURE BAG WAS RETRIEVED WITHOUT INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343136 APPLIED MEDICAL INZII UNIVERSAL RETRIEVAL SYSTEM GCJ APPLIED MEDICAL CD003 1190880

    Patients

    Seq Age Sex Outcome Treatment
    1